Valve with delayed leaflet deployment

ABSTRACT

A valve for use in a body lumen, where the valve includes a valve leaflet with delayed leaflet deployment relative an in vivo implant time. The valve includes a valve frame, a valve leaflet coupled to the valve frame. The valve leaflet includes a commissure that can reversibly seal for unidirectional flow of a liquid through the valve, and a biodegradable adhesive between the valve leaflet and the valve frame to hold at least the commissure of the valve leaflet in a static relationship relative the valve frame for a predetermined time once implanted in vivo.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/006,578, filed Jan. 14, 2011, which is a continuation of U.S. patentapplication Ser. No. 12/004,561, filed Dec. 21, 2007, each of which areherein incorporated by reference in their entirety.

TECHNICAL FIELD

The present disclosure relates generally to a valve for use in a bodylumen, and more particularly to a valve having a valve leaflet withdelayed leaflet deployment relative an in vivo implant time.

BACKGROUND

Heart failure is rapidly becoming one of the most common cardiovasculardisorders. Unfortunately, an optimal treatment for heart failure has notyet been determined.

Generally, heart failure is classified as a syndrome which develops as aconsequence of cardiac disease, and is recognized clinically bydifferent signs and symptoms that are produced by complex circulatoryand neuro-hormonal responses to cardiac dysfunction.

Dysfunction in one or both of the systolic function and/or the diastolicfunction of the heart can lead to heart failure. For example, leftventricular diastolic dysfunction is recognized as a condition leadingto morbidity, hospitalizations and death. Left ventricular diastolicdysfunction is a condition in which the left ventricle of the heartexhibits a decreased functionality. This decreased function could leadto congestive heart failure or myocardial infarction, among othercardiovascular diseases.

Treatment of left ventricular diastolic dysfunction can include the useof pharmaceuticals. Despite these treatments, improving the approach totreating diastolic dysfunction continues to be a goal of the medicalcommunity.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an embodiment of a valve of the present disclosure.

FIG. 2A illustrates an embodiment of a system having a valve of thepresent disclosure.

FIG. 2B illustrates an embodiment of a system having a valve of thepresent disclosure.

DETAILED DESCRIPTION

Embodiments of the present disclosure are directed to a valve having avalve leaflet, a system that includes the valve, and a method of makingand/or using the valve. For the embodiments, the valve leaflet has adelayed deployment relative an in vivo implant time of the valve. Forthe embodiments, the delayed deployment can be accomplished through theuse of a biodegradable adhesive (e.g., a biodegradable material) thatholds the valve leaflet in a static relationship relative the valveframe for a predetermined time. Once implanted in vivo, thebiodegradable adhesive degrades and/or erodes over the predeterminedtime to at least the point where the valve leaflet is released from itsstatic relationship relative the valve frame. Once released, the valveleaflet can then operate to control the flow of a fluid through thevalve in an essentially unidirectional manner.

As used herein, the terms “a,” “an,” “the,” “one or more,” and “at leastone” are used interchangeably and include plural referents unless thecontext clearly dictates otherwise. Unless defined otherwise, allscientific and technical terms are understood to have the same meaningas commonly used in the art to which they pertain. For the purpose ofthe present disclosure, additional specific terms are definedthroughout.

As used herein, the “valve” can be formed from a number of metals, metalalloys, biological materials and/or synthetic materials. For example,the valve leaflet can be formed from one or more of a biologicalmaterial (e.g., a non-autologous material) and/or a synthetic material(e.g., a synthetic polymer) having suitable mechanical and materialproperties. In addition, the valve frame can be formed from a syntheticmaterial, a metal and/or a metal alloy having suitable mechanical andmaterial properties. Other materials are also possible. The materialsused in forming the valve will be discussed more fully herein.

The valve of the present disclosure can be implanted in one or morevessels of a mammal (e.g., a human) body where it would be desirable toallow the valve frame to first seat (e.g., anchor) and be at least bepartially in-grown at the implant site before exposing the valve toforces imparted through the opening and closing of the valve leaflet.For the various embodiments, the valve leaflets maintain their “open”configuration (i.e., their static relationship relative the valve frame)through the use of the biodegradable adhesive, as discussed herein. Inthis “open” configuration longitudinal shear stresses through the valvecan be minimized, allowing the valve frame to seat and be in-grown atthe implant site over the predetermined time.

As used herein, the one or more “vessels” can include vessels of thecardiovascular system (e.g., arteries and veins), which can include boththe coronary and/or the peripheral vasculature, vessels of the lymphaticsystem, vessels and/or ducts of the urinary system, and/or vesselsand/or ducts of the kidney system. Other vessel locations within themammal body for implanting the valve of the present disclosure are alsopossible.

The figures herein follow a numbering convention in which the firstdigit or digits correspond to the drawing figure number and theremaining digits identify an element or component in the drawing.Similar elements or components between different figures may beidentified by the use of similar digits. For example, 110 may referenceelement “10” in FIG. 1, and a similar element may be referenced as 210in FIG. 2. As will be appreciated, elements shown in the variousembodiments herein can be added, exchanged, and/or eliminated so as toprovide any number of additional embodiments of valve and/or system. Inaddition, as will be appreciated the proportion and the relative scaleof the elements provided in the figures are intended to illustrate theembodiments of the present disclosure, and should not be taken in alimiting sense.

Various non-limiting embodiments of the present disclosure areillustrated in the figures. Generally, the valve can be implanted withina vessel to regulate the flow of a bodily fluid through the body lumenin a single direction.

FIG. 1 provides an embodiment of a valve 100 that includes a valve frame102 and a valve leaflet 104 coupled to the valve frame 102. Asillustrated, the valve 100 can be formed with a valve leaflet 104 havinga commissure 106 that can reversibly seal for unidirectional flow of aliquid through the valve 100. As discussed herein, embodiments of thevalve 100 having one leaflet 104 or more than two leaflets 104 arepossible.

The valve frame 102 also includes frame members 108 that help to definea lumen 110. For the various embodiments, the valve frame 102 can havean elongate tubular structure with a proximal end 112 and a distal end114. For the various embodiments, portions of the frame members 108define the proximal and distal ends 112, 114 of the valve frame 102.

The valve leaflet 104 also has a proximal end 116 and a distal end 118.As illustrated, the proximal end 116 of the leaflet 104 can be coupledto the valve frame 102 through a number of different techniques. Forexample, the material 120 forming the leaflet 104 can be stitched,bonded, glued or otherwise secured to the valve frame 102 so as to formthe proximal end 116 of the valve leaflet 104. In one embodiment, thematerial 120 can be secured to the valve frame 102 at a position that isat or adjacent the proximal end 112. Alternatively, the material 120 canbe secured to the valve frame 102 at a position that is between theproximal and distal ends 112, 114 of the valve frame 102. For thevarious embodiments, the material 120 forming the valve leaflet 104 candefine at least a part of the lumen 110 of the valve 100.

As illustrated, the distal end 118 of the valve leaflet 104 includes thecommissure 106 that can reversibly form to control fluid flow throughthe valve 100. As used herein, the commissure 106 is the location of thevalve leaflet 104 that releasably join and seal to allow forunidirectional flow through the valve 100. As illustrated, thecommissure 106 is approximately adjacent the distal end 118 of the valveleaflet 104.

As illustrated, the valve leaflet 104 is in an open position. For thevarious embodiments, the valve leaflet 104 can releasably joined to beheld in this open position with a biodegradable adhesive 122 so that thecommissure 106 does not help to prevent retrograde flow for at least apredetermined time after the valve has been implanted in a vessel of abody. As used herein, a “biodegradable adhesive” includes thosematerials that when exposed to a biological environment (e.g., in vivo)is chemically and/or physically degraded via one or more mechanisms.These mechanisms can include, but are not limited to, hydrolysis and/orenzymatic cleavage of the biodegradable material (e.g., scission of thepolymer backbone).

With respect to valve 100, the biodegradable adhesive 122 can bepositioned between the valve leaflet 104 and the valve frame 102 to holdat least the commissure 106 of the valve leaflet 104 in a staticrelationship relative the valve frame 102. For the various embodiments,the biodegradable adhesive 122 can originally be in the form of a liquidand/or a solid (including a gel) that can be used to join valve leaflet104 to the valve frame 102. For example, the biodegradable adhesive 122can be applied to one or both adjacent surfaces of the valve leaflet 104and the valve frame 102, where the surfaces are brought together to jointhem with the biodegradable adhesive 122. Other forms for thebiodegradable adhesive 122 are also possible.

For the various embodiments, the location(s) of and/or the surface areaused with the biodegradable adhesive 122 to hold the valve leaflet 104in the open position can vary from the proximal end 116 to the distalend 118 (or visa versa) and/or radially around the valve 100. Forexample, the biodegradable adhesive 122 can be positioned so as to holdthe valve leaflet 104 at one or more discrete attachment points betweenthe leaflet 104 and the frame 102. In an additional example, thebiodegradable adhesive 122 can be positioned so as to hold at least thevalve leaflet 104 completely along the distal end 114 of the valve frame102. In other words, the biodegradable adhesive 122 can releasably joinat least a portion of the valve leaflet 104 to the valve frame 102 alonga peripheral edge of the valve leaflet 104 to the valve frame 102. Forthe various embodiments, releasably joining the portion of theperipheral edge of the valve leaflet 104 to the valve frame 102 includesreleasably joining the peripheral edge in its entirety to the valveframe 102. Alternatively, releasably joining the portion of theperipheral edge of the valve leaflet 104 to the valve frame 102 can beat attachment points spaced equidistant from a longitudinally axis ofthe valve frame 102. For these embodiments, the biodegradable adhesive122 can hold at least the commissure 106 of the valve leaflet 104 in thestatic relationship relative the valve frame 102 for the predeterminedtime after implantation into a lumen of a body.

For the various embodiments, the biodegradable adhesive 122 can bepositioned between an outer surface (opposite the luminal surface) ofthe valve leaflet 104 and the frame member 108. In addition, thebiodegradable adhesive 122 can be located over essentially the entireouter surface of the valve leaflet 104 so as to allow the biodegradableadhesive 122 to span the openings defined by the frame member 108.

For the various embodiments, the concentration(s), type, and/or mixture(e.g., two or more different biodegradable adhesives along with otheroptional substances) of the biodegradable adhesive 122 being used tohold the valve leaflet 104 in the open position can be varied as well.As use herein, the term “concentration” includes the amount of each ofthe biodegradable adhesives (e.g., by weight) in the mixture and/orsolution forming the adhesive.

For the various embodiments, the selection of one or more biodegradableadhesives, their concentration and/or their location used in holding thevalve leaflet 104 static relative the valve frame 102 can allow thevalve leaflet 104 to release from the valve frame in a number of ways.For example, the biodegradable adhesives 122 can be used in such a wayas to allow for a progressive release of the valve leaflet 104 from oneof the proximal end 112 and/or the distal end 114 of the valve frame102. In one approach, this might be accomplished by changing theconcentration and/or having a gradient of the biodegradable adhesive(s)122 that extends from the one or both of either the proximal end 112and/or the distal end 114 of the valve frame 102.

Alternatively, the selection of one or more biodegradable adhesives 122,their concentration and/or their location can be used in such a way asto allow for each of the valve leaflets 104 to be release from theirstatic relationship in essentially their entirety at essentially thesame time. For example, different types of the biodegradable adhesives122 can be used in different regions (e.g., discrete regions) so as toallow for the progressive release of the valve leaflet 104.

For the various embodiments, the type of biodegradable adhesives caninclude, but are not limited to those compounds that erode (e.g.,bioerodible or biodegradable) so as to be absorbed by the body. As usedherein, “erode” or “erosion” includes processes by which a material thatis insoluble in water is converted into one that is water-soluble. Othertypes of biodegradable adhesives can include a variety of natural,synthetic, and biosynthetic polymers that are biodegradable, such asthose having at least a heteroatom-containing polymer backbone. Suchbiodegradable adhesives can include those having chemical linkages suchas anhydride, ester, or amide bonds, among others. These chemicallinkages can then undergo degradation through one or both of hydrolysisand/or enzymatic cleavage resulting in a scission of the polymerbackbone.

Examples of biodegradable adhesives 122 are those that includepoly(esters) based on polylactide (PLA), polyglycolide (PGA),polycaprolactone (PCL), and copolymers thereof. Other biodegradableadhesives 122 can include those that having poly(hydroxyalkanoate)s ofthe PHB-PHV class, additional poly(ester)s, and natural polymers, suchas modified poly(saccharide)s, e.g., starch, cellulose, and chitosan,which upon further hydrolysis can yield low molecular weightoligosaccharides. Poly(ethylene oxide), PEO, and/or poly(ethyleneglycol), PEG, can also be used as the biodegradable adhesive. Multiblockcopolymers of poly(ethylene oxide) (PEO) and poly(butyleneterephthalate) (PBT) are also possible for use in the biodegradableadhesives of the present disclosure, where the degradation rate can beinfluenced by PEO molecular weight and content.

For the various embodiments, the biodegradable adhesive 122 can hold atleast the commissure 106 of the valve leaflet 104 in the staticrelationship relative the valve frame 102 for a predetermined time afterimplantation into a lumen of a body. For the various embodiments, thepredetermined time after implantation can be a range of approximatetime, as the degradation of the biodegradable adhesive 122 will mostlikely proceed at a different rate for each individual patient. As such,the type(s), concentration(s), and/or location(s) of the biodegradableadhesive 122 used in any particular valve 100 may be patient specificand/or implant location specific.

For example, the biodegradable adhesive 122 can hold at least a portionof the valve leaflet 104 static relative the valve frame 102 for no lessthan one week (i.e., 7 days). After this predetermined time thebiodegradable adhesive 122 can have degraded and/or eroded to a pointthat the biodegradable adhesive 122 no longer can hold the at least aportion of the valve leaflet 104 static relative the valve frame 102.The valve leaflet 104 can then be released from the portions of thevalve frame 102 with the biodegradable adhesive 122. After beingreleased, the valve leaflet 104 can then operate to control the flow ofa fluid (e.g., blood) through the valve in an essentially unidirectionalmanner.

For the various embodiments, the predetermined time also allows thevalve frame 102 to be at least be partially in-grown at the implant site(e.g., anchor) before exposing the valve 100 to forces imparted throughthe opening and closing of the valve leaflet 104. In one embodiment, thevalve frame 102 can have one or more of a surface treatment and/or acoating that promotes and/or discourages in-growth and/or overgrowth ofthe surrounding tissues. For example, the valve frame 102 can have oneor more of the surface treatment and/or the coating that promotes tissuein-growth in regions of the valve 100 where the valve leaflet 104 wasnot attached to the valve frame 102 with the biodegradable adhesive 122.Similarly, the regions where the biodegradable adhesive 122 joints thevalve leaflet 104 and the valve frame 102 can include one or more of thesurface treatment and/or the coating that discourages in-growth and/orovergrowth of the surrounding tissues at least for the time it takes forthe biodegradable adhesive 122 to degrade and/or erode.

For the various embodiments, the biodegradable adhesive 122 and/or thevalve frame 102 can also have a predetermined structure and/or shapethat allows for tissue in-growth of the valve 100, while preventingin-growth around the valve leaflet 104 while it is in its staticrelationship to the valve frame 102. For example, the biodegradableadhesive 122 positioned between the valve leaflet 104 and the valveframe 102 can have a portion or a layer with a porosity that promotesand/or allows for tissue in-growth, while an adjacent portion of thebiodegradable adhesive 122 may not be designed to promote suchin-growth. In other words, the biodegradable adhesive 122 can have alayered structure in which the different layers and/or regions canpotentially promote different in-growth responses from the body due thephysical structure and/or morphology of the biodegradable adhesive 122.Alternatively, different types of biodegradable adhesives 122 can beused in either layers and/or patterns having the same and/or differentmorphology (e.g., structure such as porous) in trying to elicit thein-growth response discussed herein.

In some embodiments, the frame members 108 of the valve frame 102 can beformed of a variety of materials. Such materials include, but are notlimited to, metals, metal alloys, and/or polymers. The design andconfiguration of the valve frame 102 can be such that it is balloonexpandable, either fully or at least partially, and/or self expandingshape-memory materials. Examples of shape-memory materials include shapememory plastics, polymers, thermoplastic materials, and metal-alloyswhich are inert in the body. Some shape-memory materials, (e.g.,nickel-titanium alloys) can be temperature-sensitive and change shape ata designated temperature or temperature range. In one embodiment, theshape memory metal-alloy includes those made from nickel and titanium inspecific ratios, commonly known as Nitinol. Other materials are alsopossible.

For the various embodiments, the frame members 102 can have similarand/or different cross-sectional geometries along their length. Thesimilarity and/or the differences in the cross-sectional geometries canbe selected based on one or more desired functions to be elicited fromeach portion of the valve frame 102. Examples of cross-sectionalgeometries include rectangular, non-planar configuration (e.g., bent),round (e.g., circular, oval, and/or elliptical), polygonal, arced, andtubular. Other cross-sectional geometries are possible.

The valve 100 can further include one or more radiopaque markers (e.g.,tabs, sleeves, welds). For example, one or more portions of the valveframe 102 can be formed from a radiopaque material. Radiopaque markerscan be attached to and/or coated onto one or more locations along thevalve frame 102. Examples of radiopaque material include, but are notlimited to, gold, tantalum, and platinum. The position of the one ormore radiopaque markers can be selected so as to provide information onthe position, location, and orientation of the valve 100 during itsimplantation.

The valve 100 further includes the valve leaflets 104 having surfacesdefining a reversibly sealable opening (e.g., the commissure 106) forunidirectional flow of a liquid through the valve 100. Each of the valveleaflets 104 are coupled to the valve frame 102, where the leaflets 104can repeatedly move between an open state and a closed state forunidirectional flow of a liquid through a lumen of the valve 100 afterthe biodegradable adhesive 122 has degraded and/or eroded to the pointwhere the valve leaflets 104 are released from their static relationshipwith the valve frame 102. In the present example, the valve 100 includestwo of the valve leaflets 104 for a bi-leaflet configuration. Asappreciated, mono-leaflet, tri-leaflet and/or other multi-leafletconfigurations are also possible.

In some embodiments, the leaflets 104 can be derived from autologous,allogeneic or xenograft material. As will be appreciated, sources forxenograft material (e.g., cardiac valves) include, but are not limitedto, mammalian sources such as porcine, equine, and sheep. Additionalbiologic materials from which to form the valve leaflets 104 include,but are not limited to, explanted veins, pericardium, facia lata,harvested cardiac valves, bladder, vein wall, various collagen types,elastin, intestinal submucosa, and decellularized basement membranematerials, such as small intestine submucosa (SIS), amniotic tissue, orumbilical vein.

Alternatively, the leaflets 104 can be formed from a synthetic material.Possible synthetic materials include, but are not limited to, expandedpolytetrafluoroethylene (ePTFE), polytetrafluoroethylene (PTFE),polystyrene-polyisobutylene-polystyrene (SIBS), polyurethane, segmentedpoly(carbonate-urethane), polyester, polyethylene (PE), polyethyleneterephthalate (PET), silk, urethane, Rayon, Silicone, or the like. In anadditional embodiment, the synthetic material can also include metals,such as stainless steel (e.g., 316L) and Nitinol. These syntheticmaterials can be in a woven, a knit, a cast or other known physicalfluid-impermeable or permeable configurations. In addition, gold platedmetals can be embedded in the leaflet 104 material (e.g., a sandwichconfiguration) to allow for visualization of the leaflets 104 postplacement.

As will be appreciated, the valve 100 (e.g., valve frame 102 and/orvalve leaflets 104) can be treated and/or coated with any number ofsurface or material treatments. Examples of such treatments include, butare not limited to, bioactive agents, including those that modulatethrombosis, those that encourage cellular in-growth, through-growth, andendothelialization, those that resist infection, anti-thromobogeniccoatings, and those that reduce calcification. One example of a suitablecoating for at least the valve frame 102 is a stent frame coatingprovided under the trade designator Taxus® from Boston Scientific.

Referring now to FIGS. 2A-2B, there is illustrated different embodimentsof a system 230 according to the present disclosure. For each system230, there is at least a valve 200, as described herein, positioned atleast partially over an elongate delivery catheter 232. As illustrated,the elongate delivery catheter 232 can include a guide wire lumen 234for receiving and passing a guide wire 236.

The embodiment of the system 230 illustrated in FIG. 2A further includesan expandable balloon 238 positioned around at least a portion of theelongate delivery catheter 232, and where the valve 200 is positioned atleast partially over the expandable balloon 238. For this embodiment,the elongate delivery catheter 232 further includes an inflation lumen240 that extends through the elongate delivery catheter 232 from aninflation port 242 to an expandable volume defined at least in part bythe expandable balloon 238 and the elongate delivery catheter 232. Fluiddelivered under pressure through the inflation port 242 can then be usedto inflate the expandable balloon 238 thereby at least partially, orcompletely, delivering the valve 200 to the desired location.

In some embodiments, the expandable balloon 238 can be a perfusionballoon. A perfusion balloon can be used to radially expand the valveframe of the valve 200 while allowing fluid, for example, blood, to passthrough the delivery catheter 232 and valve 200 while the valve 200 isbeing positioned in the vasculature.

In an alternative embodiment, FIG. 2B provides an illustration of asystem 230 that includes a retractable sheath 250 positioned around atleast a portion of the elongate delivery catheter 232. In addition, atleast a portion of the valve 200 can be positioned between the elongatedelivery catheter 232 and the retractable sheath 250 to hold the valve200 in a delivery state. For example, FIG. 2B illustrates an embodimentin which the retractable sheath 250 is positioned around at least aportion of the delivery catheter 232 to releasably hold the valve 200 inits compressed delivery (i.e., undelivered) state. The retractablesheath 250 can be retracted to allow the valve 200 to radially expandfrom the elongate delivery catheter 232, where the valve frame 202 isformed at least partially from a shape memory material such as Nitinol.

Alternatively, the valve frame 202 can be formed of a material with aspring bias, where the valve 200 can expand when the sheath 250 has beenremoved. Examples of materials with a spring bias can include, but arenot limited to, medical grade stainless steel (e.g., 316L), titanium,tantalum, platinum alloys, niobium alloys, cobalt alloys, alginate, orcombinations thereof.

In one embodiment, the retractable sheath 250 can extend co-axially withthe elongate delivery catheter 232, where the sheath 250 can be movedlongitudinally (e.g., slide) relative the elongate delivery catheter 232to allow the valve 200 to radially expand from its delivery state to itsdeployed state. In some embodiments, moving the retractable sheath 250relative the delivery catheter 232 can be accomplished by pulling aproximal end 256 of the sheath 250 relative a proximal end 258 of thedelivery catheter 232.

As illustrated in FIGS. 2A and 2B, the valve 200 also illustrated anembodiment of the present disclosure in which the biodegradable adhesivecan be used to hold the valve leaflet 204 at one or more discreteattachment points 254 to the valve frame 202. As illustrated, theportions of the peripheral edge of the valve leaflet can be releasablyjoined to the valve frame at attachment points spaced equidistant from alongitudinally axis 260 of the valve frame.

In the compressed state, as illustrated in FIGS. 2A and 2B, attachingthe valve leaflet 204 at the one or more discrete attachment points 254to the valve frame 202 allows at least a portion of the commissure 206of the valve leaflet 204 to gather toward the longitudinal axis 260 whenthe valve frame 202 is in a radially compressed state around either theexpandable balloon 238 or compressed between the retractable sheath 250and the elongate catheter 232.

In additional embodiment, the system can include both an expandableballoon positioned around at least a portion of the elongate deliverycatheter and a retractable sheath. The valve frame can be at leastpartially self-expanding (or completely self-expanding), whereretracting the sheath allows the valve to expand from its delivery statetowards its deployed state. The expandable balloon can then be used tofully deploy, secure, and/or more fully seat the valve frame at thedesired implant location.

Each of the delivery catheter 232 and/or the retractable sheath 250 canbe formed of a number of materials. Materials include polymers, such asPVC, PE, POC, PET, polyamide, mixtures, and block co-polymers thereof.In addition, each of the delivery catheter 232 and/or the retractablesheath 250 can have a wall thickness and an inner diameter sufficient toallow the structures to slide longitudinally relative each other, asdescribed herein, and to maintain the valve 200 in a delivery state, asdiscussed herein.

In an additional embodiment, the valve 200 of the present disclosure caninclude anchoring members attached to the valve frame or frame members.Anchoring members can include barbs, hooks, etc.

For the various embodiments, the valve of the present disclosure may beused with a patient that has been diagnosed with certain forms of heartfailure, such as those having an essentially normal ejection fraction,but displaying signs and symptoms of heart failure. For example, indealing with left ventricular (LV) diastolic dysfunction, improving leftatrial (LA) systole can aid in the filling of a stiff LV (although notcompletely due to retrograde blood flow back into the pulmonary venouscirculation). The valve of the present disclosure may help to improvethe LA systolic contribution to LV diastolic filling when implanted atthe junction where the pulmonary veins and the LA meet. Potentially,these valves will help improve the work done by the LA systole in movinga much greater percentage of blood forward into the LV during diastole.

In addition, positioning the system having the valve as discussed hereinincludes introducing the system into the cardiovascular system of thepatient using minimally invasive percutaneous, transluminal techniques.For example, a guidewire can be positioned within the cardiovascularsystem of a patient that includes the predetermined location. The systemof the present disclosure, including the valve as described herein, canbe positioned over the guidewire and the system advanced so as toposition the valve at or adjacent the predetermined location. In oneembodiment, radiopaque markers on the catheter and/or the valve, asdescribed herein, can be used to help locate and position the valve.

The valve can be deployed from the system at the predetermined locationin any number of ways, as described herein. In one embodiment, valve ofthe present disclosure can be deployed and placed in any number ofcardiovascular locations. For example, valve can be deployed and placedwithin an artery and/or vein (e.g., a pulmonary vein) of a patient. Inone embodiment, arteries and/or veins of a patient include those of theperipheral vasculature and/or the cardiac vasculature. For example,delivery of one or more of the valves of the present disclosure to thepulmonary veins can be accomplished through transseptal puncture fromthe right atria into the left atria. In addition, embodiments of thevalve have the potential to be used in a number of different vessels(e.g., urinary and/or lymph) where more stringent control over fluidmovement is desired. Other locations are also possible.

Delivery of the valve can be accomplished through a number of differentimplant techniques. For example, the valve of the present disclosure canbe implanted through the use of percutaneous delivery techniques, wherethe valve can be positioned at a predetermined location with thedelivery catheter, as discussed herein. The valve can then be deployedfrom the delivery catheter at the predetermined location. The cathetercan then be removed from the predetermined location.

The valve, once implanted, maintains its open luminal configuration inwhich the proximal end portion and the distal end portion of the valveleaflet are retained in a static relationship relative the valve frameafter removal of the delivery catheter. In other words, the valveleaflet(s) are held in their “open” position through the use of thebiodegradable adhesive, as discussed herein. Once implanted, thebiodegradable adhesive is exposed to body fluids (e.g., blood) thatcause its degradation and/or erosion to the point after thepredetermined time where the valve leaflet(s) is released from itsstatic relationship relative the valve frame.

During the predetermined time, however, the open luminal configurationallows for uncontrolled blood flow through the valve. Retaining thevalve leaflets to create this open luminal configuration allowslongitudinal shear stresses on the valve frame to be minimized duringthe predetermined time, as the valve leaflets are not opening andclosing to provide for unidirectional flow through the valve. Duringthis predetermined time, tissue in-growth can occur around the valveframe. This tissue in-growth can be promoted during the predeterminedtime through the use of coatings and/or surface treatments, such asthose discussed herein.

While the present disclosure has been shown and described in detailabove, it will be clear to the person skilled in the art that changesand modifications may be made without departing from the spirit andscope of the disclosure. As such, that which is set forth in theforegoing description and accompanying drawings is offered by way ofillustration only and not as a limitation. The actual scope of thedisclosure is intended to be defined by the following claims, along withthe full range of equivalents to which such claims are entitled. Inaddition, one of ordinary skill in the art will appreciate upon readingand understanding this disclosure that other variations for thedisclosure described herein can be included within the scope of thepresent disclosure.

In the foregoing Detailed Description, various features are groupedtogether in several embodiments for the purpose of streamlining thedisclosure. This method of disclosure is not to be interpreted asreflecting an intention that the embodiments of the disclosure requiremore features than are expressly recited in each claim. Rather, as thefollowing claims reflect, inventive subject matter lies in less than allfeatures of a single disclosed embodiment. Thus, the following claimsare hereby incorporated into the Detailed Description, with each claimstanding on its own as a separate embodiment.

The invention claimed is:
 1. A valve, comprising: a valve frame; a valveleaflet coupled to the valve frame, where the valve leaflet has an openstate and a closed state, and movement of the valve leaflet between theopen state and the closed state provides for unidirectional flow of aliquid through the valve; and a biodegradable adhesive at one or moreattachment points between the valve leaflet and the valve frame, thebiodegradable adhesive holding the valve leaflet in the open state for apredetermined time of no less than one week after implantation into alumen of a body.
 2. The valve of claim 1, the valve further including afirst treatment in regions other than the one or more attachment points,said treatment promoting tissue in-growth after implantation into alumen of a body.
 3. The valve of claim 2, the valve further including asecond treatment at the one or more attachment points to prevent tissuein-growth at least for the predetermined time after implantation into alumen of a body.
 4. The valve of claim 1, the biological adhesivecomprising a porous first portion for tissue in-growth afterimplantation into a lumen of a body.
 5. The valve of claim 1, thebiological adhesive having a layered structure.
 6. The valve of claim 5,wherein said layered structure promotes tissue in-growth afterimplantation into a lumen of a body.
 7. The valve of claim 6, thebiodegradable adhesive being different types of biodegradable adhesive,the layered structure formed of the different types of biodegradableadhesives.
 8. The valve of claim 1, where the valve frame includes adistal end and where the biodegradable adhesive holds the valve leafletcompletely along the distal end of the valve frame.
 9. The valve ofclaim 1, where the valve leaflet includes a commissure that canreversibly seal for unidirectional flow of a liquid through the valveafter the predetermined time, further including allowing at least aportion of the commissure of the valve leaflet to gather toward thelongitudinal axis when the valve frame is in a radially compressedstate.
 10. A system, comprising: an elongate delivery catheter; and avalve positioned at least partially over the elongate delivery catheter,where the valve includes: a valve frame; a valve leaflet coupled to thevalve frame, where the valve leaflet has an open state and a closedstate, and movement of the valve leaflet between the open state and theclosed state provides for unidirectional flow of a liquid through thevalve; and a biodegradable adhesive at one or more discrete attachmentpoints between the valve leaflet and the valve frame, the biodegradableadhesive holding the valve leaflet in the open state for a predeterminedtime of no less than one week after implantation into a lumen of a body.11. The system of claim 10, where the elongate delivery catheterincludes an expandable balloon positioned around at least a portion ofthe elongate delivery catheter, and where the valve is positioned atleast partially over the expandable balloon.
 12. The system of claim 10,where the elongate delivery catheter includes a retractable sheathpositioned over at least a portion of the valve, where the retractablesheath can be retracted to release the valve from the elongate deliverycatheter.
 13. The system of claim 10, where the valve frame includes adistal end and where the biodegradable adhesive holds the valve leafletcompletely along the distal end of the valve frame.
 14. The valve ofclaim 10, the valve further including a first treatment in regions ofthe valve other than the one or more attachment points, said treatmentpromoting tissue in-growth after implantation into a lumen of a body.15. The valve of claim 14, the valve further including a secondtreatment at the one or more attachment points to prevent tissuein-growth at least for the predetermined time after implantation into alumen of a body.
 16. The valve of claim 10, the biological adhesivecomprising a porous first portion for tissue in-growth afterimplantation into a lumen of a body.
 17. The valve of claim 10, thebiological adhesive having a layered structure.
 18. The valve of claim17, wherein said layered structure promotes tissue in-growth afterimplantation into a lumen of a body.
 19. The valve of claim 18, thebiodegradable adhesive being different types of biodegradable adhesive,the layered structure formed of the different types of biodegradableadhesives.
 20. A valve, comprising: a valve frame; a valve leafletcoupled to the valve frame, where the valve leaflet has an open stateand a closed state, and movement of the valve leaflet between the openstate and the closed state provides for unidirectional flow of a liquidthrough the valve; and a biodegradable adhesive at one or moreattachment points between the valve leaflet and the valve frame, thebiological adhesive comprising a porous first portion for tissuein-growth after implantation into a lumen of a body, the biodegradableadhesive holding the valve leaflet in the open state for a predeterminedtime of no less than one week after implantation into a lumen of a body.